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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05788822
Other study ID # SZ-MVA-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 8, 2022
Est. completion date December 2025

Study information

Verified date March 2023
Source Nanjing University
Contact Haixiang Sun, MD
Phone 025-83106666
Email haixiang_sun@nju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test MVA on improving pregnancy outcome in elderly infertile patients undergoing invitro fertilization (IVF). The main question it aims to answer is whether MVA could improve embryo haploid rate. Participants requested IVF are asked to randomly culture equal numbers of oocyte and embryo with or without MVA. Therefore, sibling oocytes were randomly divided into test group and control group.


Description:

After being informed about the study and potential risks, all participants will write the informed contents. This study is a randomized controlled study co compare different treatment methods on the embryo development. Sibling eggs were randomly divided into test group and control group. Specific method of randomization: all the eggs of each subject were distributed into two dishes (dish 1 and dish 2). If the oocyte number is odd, put the extra oocyte into dish 1. Using statistical software, the two dishes were randomly treated as test group and control group. Thus, a random allocation table was generated and a separate random envelope was made for each subject. The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. Each selected subject must open the random envelope. The subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (COCs) were obtained and fertilized in vitro. The test group oocytes were cultured with MVA, while the control oocytes were cultured without MVA. Thus, half of the eggs from each elderly infertile patient were treated with MVA.


Recruitment information / eligibility

Status Recruiting
Enrollment 148
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Female
Age group 38 Years to 42 Years
Eligibility Inclusion Criteria: 1. 38 years = age = 42 years; 2. Number of IVF/ICSI cycles = 2 Exclusion Criteria: 1. Egg donor cycle 2. Chromosome abnormality; 3. Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases; 4. Patients with repeated implantation failure

Study Design


Intervention

Dietary Supplement:
Mevalproic acid
Methovalerate pathway is a metabolism of cholesterol and isoprenoid synthesized from acetyl coenzyme A Pathway, which plays a key role in human health and disease, is also necessary for human cells to maintain normal functions. There are a series of important metabolic intermediates in the mevalproate pathway, such as farnesyl diphosphate and incense Folyl vanillin diphosphates, which modify proteins through isoprene, play an important role in regulating cell function. In addition, the latest research shows that valproic acid, the key metabolic intermediate of valproic acid pathway, being the synthetic precursor of cholesterol and isoprene, it can activate insulin growth factor (IGF)1-R and mTOR signals and maintain cell function by mediating histone function

Locations

Country Name City State
China Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Embryo haploid rate Preimplantation genetic testing (PGT) was used to test embryo haploid rate one month after oocyte retrival
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